Breast CancerNCT01684735
Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation
An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy
Who may be able to join
- core biopsy with diagnosis of breast cancer
- start of neo-adjuvant chemotherapy
Who cannot join
- magnetic resonance imaging incompatibility
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.
- Conditions
- Breast Cancer
- Keywords
- diffusion-weighted magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with BRCA and chemotherapy | women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to chemotherapy
outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantal Van Ongeval, MD, Phd, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684735
- Sponsor's protocol ID
- B322201213618
- Status last verified
- Sep 2012
- First submitted
- 14 May 2012
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted Magnetic Resonance Imaging of the Breast During Chemotherapy: Response Evaluation
- ClinicalTrials.gov ID
- NCT01684735
- Acronym / sponsor ID
- B322201213618
- Conditions
- Breast Cancer
- Keywords
- diffusion-weighted magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with BRCA and chemotherapy | – | –women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy
Key inclusion criteria (2 listed)
- core biopsy with diagnosis of breast cancer
- start of neo-adjuvant chemotherapy
Key exclusion criteria (1 listed)
- magnetic resonance imaging incompatibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response to chemotherapy
Time frame: 1 year
outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantal Van Ongeval, MD, Phd principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to chemotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.